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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01546077
Other study ID # HLOCSTIM1
Secondary ID
Status Recruiting
Phase Phase 4
First received February 3, 2012
Last updated November 9, 2012
Start date January 2012

Study information

Verified date November 2012
Source Attikon Hospital
Contact Tatiana F Sidiropoulou, MD, PhD
Phone 00302105832371
Email tatianasid@gmail.com
Is FDA regulated No
Health authority Greece: Ethics CommitteeGreece: Ministry of Health and Welfare
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess the efficacy of the hydrolocalization technique for placement of popliteal perineural catheters in comparison with the stimulating catheters. A non inferiority trial.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date
Est. primary completion date March 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- adults

- BMI less than 30

Exclusion Criteria:

- known allergies to local anesthetics or other drugs used

- patient refusal

- any local or systemic contraindication to the use of popliteal block

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Placement of perineural catheters with Hydrolocalization technique using
Placement of perineural catheters in the popliteal region comparing two techniques. while the drugs used are the same (ropivacaine 0.6% for initial bolus and 0.2% for continuous technique) we will compare dosage required in each group

Locations

Country Name City State
Greece Attikon Hospital Athens
Italy Policlinico Tor Vergata Rome

Sponsors (1)

Lead Sponsor Collaborator
Attikon Hospital

Countries where clinical trial is conducted

Greece,  Italy, 

References & Publications (1)

Saranteas T, Adoni A, Sidiropoulou T, Paraskeuopoulos T, Kostopanagiotou G. Combined ultrasound imaging and hydrolocalization technique for accurate placement of perineural catheters. Br J Anaesth. 2011 Dec;107(6):1008-9. doi: 10.1093/bja/aer375. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary consumption of local anesthetics 36 hours PO No
Secondary pain scores 36 hours postoperatively No
See also
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Terminated NCT01615939 - A Study Comparing Continuous Sciatic Nerve Block to Single Shot Sciatic Nerve Block Phase 4
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Enrolling by invitation NCT04575688 - Periarticular Injection Versus Popliteal Block Phase 4
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Completed NCT04134962 - Evaluation of a New Tool for Measuring Hindfoot Alignment Under Load and in 3D.
Enrolling by invitation NCT04872322 - Effect of Ropivacaine During Popliteal Nerve Block in Foot and Ankle Surgery Phase 3